Treating dysfunctional cardiac tissue

• US 10,624,744 B2
• Filed: 02/12/2018
• Issued: 04/21/2020
• Est. Priority Date: 10/03/2007
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Annest, Lon S., Argento, Claudio, Butler, William, Heflin, Ernest
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/894,753
• Publication Number:
  US 20190254825A1
• Time in Patent Office: 799 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0408 Rivets other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0608 : J-shaped
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Claims

1. A system for treating a heart of a patient via a percutaneous heart access comprising:

a first catheter that is configured for advancing a distal end of the first catheter through a femoral vein or an internal jugular vein, through a vena cavae and a right atrium of the heart, and through a tricuspid value into a right ventricle of the heart;

an introducer that is disposed within a lumen of the first catheter and that is advanceable from the distal end of the first catheter when the distal end of the first catheter is positioned adjacent a septum of the heart, the introducer being configured to perforate the septum subsequent to advancement of the introducer from the distal end of the first catheter;

a guidewire that is disposed within the lumen of the first catheter and that is advanceable from the distal end of the first catheter through the perforation in the septum so that a distal end of the guidewire is positioned within a left ventricle of the heart, the guidewire and first catheter being configured so that the distal end of the first catheter is advanceable over the guidewire and through the perforation in the septum so that the distal end of the first catheter is positionable within the left ventricle adjacent an anterior or lateral wall of the left ventricle, the introducer being further configured to perforate the anterior or lateral wall of the left ventricle when the first catheter is positioned adjacent thereto, and the guidewire being advanceable from the distal end of the first catheter through the perforation in the anterior or lateral wall of the left ventricle so that the distal end of the guidewire is positioned external to the heart;

a first anchor that is deliverable percutaneously through the lumen of the first catheter and that is deliverable from the first catheter through the perforation in the anterior or lateral wall of the left ventricle, the first anchor being configured for positioning on an exterior surface of the anterior or lateral wall; and

a second anchor that is deliverable percutaneously through the lumen of the first catheter to a position adjacent the perforation in the septum within the right ventricle; and

a tension member that operably couples the first anchor and the second anchor and that is configured to draw the septum and anterior or lateral wall toward one another via tension that is applied between the first anchor and the second anchor.

2. The system of claim 1, further comprising a second catheter that is insertable through the lumen of the first catheter so that a distal tip of the second catheter is positioned adjacent the septum, the second catheter being configured to dilate the perforation through the septum to enable advancement of the first catheter and/or second catheter across the septum.

3. The system of claim 2, wherein the second catheter is further configured to dilate the perforation through the anterior or lateral wall to enable advancement of the first catheter and/or second catheter across the anterior or lateral wall.

4. The system of claim 2, wherein the distal tip of the second catheter is conical shaped.

5. The system of claim 2, wherein the distal tip of the second catheter is curved so that the second catheter faces tissue of the heart when the second catheter is advanced from the distal end of the first catheter.

6. The system of claim 1, wherein the introducer is configured to perforate the septum and/or anterior or lateral wall via electromagnetic energy.

7. The system of claim 1, wherein the guidewire is the introducer.

8. The system of claim 1, wherein the first anchor and/or second anchor are configured for advancement through the lumen of the first catheter in a low profile configuration and are further configured to deploy from the low profile configuration subsequent to deployment of the first anchor and/or second anchor from the lumen of the first catheter.

9. A system for treating a heart of a patient comprising:

a catheter that is configured so that a distal end of the catheter that is advanceable percutaneously through an atrium of the heart and into a first chamber of the heart, the catheter being further configured so that the distal end of the catheter is positionable adjacent a first wall of the heart;

an elongate body that is disposed within a lumen of the catheter and that is advanceable from the distal end of the catheter to perforate dysfunctional tissue of the first wall of the heart;

a guidewire that is disposed within the lumen of the catheter and that is advanceable from the distal end of the catheter through the first wall so that a distal end of the guidewire is positioned within a second chamber of the heart, the catheter being configured so that the distal end of the catheter is advanceable over the guidewire, through the first wall, and into the second chamber of the heart, the elongate body being advanceable from the distal end of the catheter within the second chamber to perforate dysfunctional tissue of a second wall of the heart, and the guidewire being advanceable from the distal end of the catheter through the second wall so that the distal end of the guidewire is positioned external to the heart;

a first anchor that is deliverable, via the catheter, to a position adjacent the second wall of the heart;

a second anchor that is deliverable, via the catheter, to a position adjacent the first wall of the heart; and

a tension member that operably couples the first anchor and the second anchor and that is configured to draw the first wall and the second wall toward one another via tension that is applied between the first anchor and the second anchor.

10. The system of claim 9, wherein the first anchor is configured for positioning on an exterior surface of the second wall.

11. The system of claim 9, wherein the elongate body is a second catheter that is insertable through the lumen of the catheter, and wherein the second catheter is configured to dilate the perforation in the first wall and/or second wall.

12. The system of claim 11, wherein a distal tip of the second catheter is tapered to dilate the perforation in the first wall and/or second wall.

13. The system of claim 9, wherein the elongate body is configured to perforate the first wall and/or second wall via electromagnetic energy.

14. The system of claim 13, wherein the elongate body is the guidewire.

15. The system of claim 9, wherein the first anchor and the second anchor are deliverable percutaneously through the lumen of the catheter.

16. The system of claim 15, wherein the first anchor and/or second anchor are configured for advancement through the lumen of the catheter in a low profile configuration and are deployable from the low profile configuration subsequent to deployment of the first anchor and/or second anchor from the lumen of the catheter.

17. The system of claim 16, further comprising a push catheter that is insertable through the lumen of the catheter and that is operable with the second anchor to deploy the second anchor from the lumen of the catheter.

18. The system of claim 9, wherein the system is configured so that all components of the system that access the heart are deliverable through a single incision in the body.

19. The system of claim 9, further comprising a hemostasis valve that is positionable within an incision in patient and that is configured so that the catheter is insertable through the hemostasis valve to access the heart.

20. The system of claim 9, further comprising a locking mechanism that is deliverable, via the catheter, into the first chamber and that is positionable against the second anchor to secure the second anchor in position about the first wall of the heart.